The Sorry List Of Johnson & Johnson Troubles

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oh-myFor those struggling to keep track of all the Johnson & Johnson recalls and misdeeds over the past year, the FDA web site is a treasure trove of information. The agency offers a handy-dandy tally of all of the millions of bottles of over-the-counter medications recalled this year as well as a dirty laundry list of manufacturing problems at its McNeil Consumer Healthcare unit.

To wit, there are nine - count ‘em, nine - separate listings for extensive recalls this year of such venerable products as Tylenol, Mylanta, Motrin, Rolaids and Benadryl, which means the tally is incomplete (see this). How so? The ‘phantom recalls’ that were disclosed by the House Committee on Oversight and Government Reform took place last year (see here and here)

Elsewhere, the FDA lists no fewer than 35 inspection reports, 483 inspectional observation reports and warning letters (see the list) in connection with the ongoing gaffes at its Fort Washington, Pa., facility, which is currently shuttered and teeming with consultants, and the Las Piedras, Puerto Rico, plant that at least one analyst believes stands a good chance of meeting a similar fate (look here). In fact, a consent decree appears increasingly possible, according to one analyst.

After chatting with his experts, Wells Fargo Securities analyst Larry Bigelsen writes in an investor note this morning that “we now see a strong likelihood of near-term FDA enforcement action,” although the feedback he received varies from a 20 percent change to “virtual certainty” that Las Piedras will be shut down under a consent decree or injunction.”

Since such problems can last a year or so, he estimates that J&J could lose about $1.2 billion in sales next year, or twice what the health care giant is expected to lose this year thanks to the Fort Washington shutdown. That’s because most of the OTC drugs sold in the US are made at Las Piedras. As for this year, he figures J&J is losing about $737 million in sales, or 1.2 percent of companywide revenue. This may seem like a meager percentage, but given what he calls a “near-term pipeline news vacuum,” he downgraded J&J shares.

UPDATE: No sooner did we post than Johnson & Johnson disclosed yet another recall of Rolaids and suspended production of Rolaids Extra Strength Softchews, Rolaids Extra Strength plus Gas Softchews, and Rolaids Multi-Symptom plus Anti-Gas Softchews. Production will not resume until the problem haves been fixed (see the statement). Ed Towns, the outgoing committee chair, had this to say: “Today’s recall provides a troubling indication that the company continues to exhibit serious shortcomings with its quality control procedures.”

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  1. While I had seen the media announcments of the Rolaids recall, I didn’t actually read the company page until a few minutes ago through Ed’s link. One sentence struck me:

    “This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).”

    Recall ‘press releases’ usually have that message but, to my memory, they use words like ‘notify’ or ‘coordinate’ - NOT “with the knowledge.”

    Now why would they say it “THAT WAY?”

  2. As someone who has conducted recalls, that language is common in most recall letters. Not much to read into.

  3. Josh:

    Then I will blame my long-term memory for being faulty. Several recent recalls have used the text: “in consultation with the U.S. Food and Drug Administration (FDA)…”

    BUT ‘recent’ doesn’t make a valid sample.

    Thanks for the feedback.

  4. No worries Searching. I have seen “…with the full knowledge of the FDA” and “..the FDA is aware of…”. If anyone doesn’t put that, I would start questioning if the agency actually knows about it.

  5. Nice post Ed. When taken in its complete context over the last three years, we are seeing the meltdown of a once-admired company. The much lauded J&J Credo is a joke, thanks to Mr. Weldon. The company is an embarassment to the industry. And I won’t even begin to address the issue of patient safety. The implosion of J&J ranks as my #1 story of the industry for the year.

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